D-Glucitol, 1,3:2,4-bis-O-[(4-chlorophenyl)methylene]-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-01-20 - 2012-04-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 439

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EU Method B46

Deviations:

no

Principles of method if other than guideline:

- Commission Regulation (EC) No. 761/2009, Method B.46, adopted 23. July 2009: “In Vitro Skin Irritation: Reconstructed human epidermis model test”
- OECD Guideline for the Testing of Chemicals, Version 439, 22. July 2010, “In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method”
- ECVAM international validation study on in vitro tests for acute skin irritation: Report on the validity of the EPISKIN and EpiDerm assays and on the Skin Integrity Function Test (Altern Lab Anim. 2007 Dec; 35 (6): 559-601).
- Protocol for IN VITRO EpiDerm™ SKIN IRRITATION TEST (EPI-200-SIT), Rev. 3/23/2009, MatTek Corporation, Ashland, MA 01721, USA

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(1R)-1-[(4R,4aR,8aS)-2,6-bis(4-chlorophenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol

EC Number:

700-591-1

Cas Number:

82203-23-4

Molecular formula:

C20H20Cl2O6

IUPAC Name:

(1R)-1-[(4R,4aR,8aS)-2,6-bis(4-chlorophenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol

Details on test material:

- Name of test material (as cited in study report): (1R)-1-[(4R,4aR,8aS)-2,6-bis(4-chlorophenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
- Physical state: solid (white powder)
- Expiration date of the lot/batch: December 2012
- Storage condition of test material: Room Temperature: (20 ± 5°C); Keep away from humidity

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Vehicle:

other: serum-free DMEM medium

Details on test system:

TEST SITE
- % coverage: 100 %

REMOVAL OF TEST SUBSTANCE
- Washing (if done): DPBS-Buffer
- Time after start of exposure: 35 min.. 60 min

SCORING SYSTEM: formazan production is calculated as % photometric absorption compared with the mean of the negative control

Control samples:

not required

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
13.4 mg (tissue 1)
22.9 mg (tissue 2)
24.3 mg (tissue 3)

VEHICLE
- Lot/batch no. (if required): 030112TMC

Duration of treatment / exposure:

1h

Duration of post-treatment incubation (if applicable):

35 - 60 min

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: % Formazan production

Value:

135.1

Remarks on result:

other: threshold for irritation (>50% of negative control = non-irritant)

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item (1R)-1-[(4R,4aR,8aS)-2,6-bis(4-chlorophenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol showed no skin irritation potential [values are well above the treshold for irritation potential (50%)].